Natural tooth powder tablets

ABSTRACT

Disclosed are compositions that include a combination of natural tooth powder ingredients pressed into tablet form, and methods of making the composition, and to methods of enhancing dental hygiene that includes administration of the composition. The compositions include natural ingredients such as xylitol and at least one tooth cleaning agent, and can be formed into a tablet suitable for cleaning the teeth without the use of a toothbrush or water.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Divisional Application of U.S. patent applicationSer. No. 16/459,828, filed Jan. 9, 2018, which claims the benefit ofpriority to U.S. Provisional Patent Application No. 62/694,694, filedJul. 6, 2019, the disclosures of each of which are expresslyincorporated by reference in its entirety.

FIELD

The embodiments relate to a composition that includes a combination ofnatural tooth powder ingredients pressed into tablet form, to methods ofmaking the composition, and to methods of enhancing dental hygiene thatincludes administration of the composition.

BACKGROUND

Maintaining oral hygiene is necessary in preventing gum and mouthdiseases and keeping teeth healthy and attractive. The dental careindustry is dedicated to facilitating oral hygiene, including cleaningand whitening teeth, freshening breath, and intensive preventive carefor various oral diseases. There are numerous oral care compositions ina variety of forms that can be used by consumers to assist inmaintaining oral hygiene.

Most of these compositions are in gel or paste form made with glycerine,hydrated silica and sorbitol and include synthetic chemicals like sodiumlauryl sulfate (SLS). Other compositions are available in powder formwith a sodium bicarbonate base to provide effervescence when chewed.

Crest® and Colgate® brands have many products for use in cleaning themouth, gums and teeth, and that protect tooth enamel in paste and powderform. Some of the components used in these products, however, have beenknown to cause ulcers on the tongue and gums and other problems whenused over long periods of time. The products also often containartificial dyes and preservatives. Many people currently avoidartificial and synthetic products and wish to purchase products that aremade with more natural ingredients, while at the same time with topurchase products that have a pleasant taste.

Some natural tooth powder companies, including Lush Cosmetics® and EcoDent®, offer SLS-free formulations that include tooth powder or pressedtablets, but some of these formulations include sorbitol, an ingredientavoided by consumers due to bloating, gas and irritation, as well ascolor and filler ingredients like titanium dioxide which consumers mayavoid due to health risks. Powder dentifrice forms also are messy andunhygienic when used by dipping a wet toothbrush into the powder forapplication. Both Lush Cosmetics® and Eco Dent® products also includesodium bicarbonate, which some consumers avoid due to its abrasivenessto enamel when present in high concentrations. In addition, it isdifficult to unmask the flavor of such products, even with the use ofessential oils or synthetic sweeteners, and neither product offers afluoride option that many customers desire.

In addition to the products currently on the market, a number ofdocuments exist that disclose various dentifrice products. For example,U.S. Pat. No. 3,342,687 discloses oral preparations containing ananti-microbial agent. A chewable tablet is disclosed, having thefollowing formulation:

CHEWABLE TABLET FOR BRUSHING Parts Insoluble sodium metaphosphate 32.59Dicalcium phosphate dihydrate 4.03 Poly(ethylene glycol) MW about 60005.00 Saccharine 0.25 Sodium carboxymethylcellulose 1.25 Sodium laurylSulfate 2.25 Starch 3.0 Mannitol 47.3 Talc 0.5 Magnesium stearate 1.25Flavor, color, etc. 2.48 Antimicrobial agent of Example I 0.1

The tablet is employed as a dentifrice by introducing into the mouth atablet thereof having a weight of about 0.5 grams, crushing it betweenthe teeth, and then brushing the teeth in the usual fashion with salivaacting as a fluid vehicle for the crushed tablet particles.

U.S. Pat. No. 5,089,255 discloses a dentifrice that includes xylitol andfluoride ions. The disclosed dentifrice is said to be useful inremineralizing demineralized portions of teeth by treatment with anon-astringent composition containing about 10-20% xylitol, and at leastone fluoride ion-providing compound in a total amount sufficient toprovide about 150 ppm to about 1800 ppm of fluoride ions, with sodiumfluoride providing a predominant proportion of such fluoride ions. U.S.Pat. No. 3,932,604 also discloses dentifrices that include xylitol. Thedentifrice contains non-cariogenic xylitol which has the sweeteningstrength of sucrose and which also serves as a humectant.

U.S. Pat. No. 5,496,541 (the “'541 patent”) discloses the use of xylitolin dentifrice compositions. Xylitol-containing toothpastes have beensold for many years. The most common Xylitol concentration in currentEuropean toothpastes is 10 percent by weight. The most common surfactantis Sodium lauryl Sulfate (SLS). The '541 patent states that there arepresently no commercial toothpaste products containing at least 10percent by weight of Xylitol, plus a mild Surfactant and no SLS.

U.S. Patent Application Publication No. 2009/0087501 discloses oralcompositions having at least two botanical active ingredients derivedfrom plants. The oral composition also includes an orally acceptablevehicle to deliver an effective amount of the at least two activeingredients in vivo. The botanical active ingredients provideparticularly efficacious antimicrobial (antibacterial, antiviral, and/orantifungal), antioxidant, anti-inflammatory, anti-ageing, and/or healingproperties to the oral compositions. The '501 publication discloses thatthe oral composition is in the form of a lozenge, bead, tablet orchewing gum or other similar solid delivery system. Such deliverysystems are well known and generally entail stirring the activeantioxidant agent into a warm base with flavor, and non-cariogenicsweeteners. The '501 publication further discloses the orally acceptablevehicle or carrier in a lozenge bead or tablet is a non-cariogenic,solid water-soluble poly-hydric alcohol (polyol) such as mannitol,xylitol, sorbitol, malitol, hydrogenated starch hydrozylate,hydrogenated glucose, hydrogenated disaccharides or hydrogenatedpolysaccharides, in an amount of about 85 to about 95% of the totalcomposition. Emulsifiers such as glycerin, and tableting lubricants, inminor amounts of about 0.1 to 5%, may be incorporated into the tablet,bead or lozenge formulation to facilitate the preparation of the tabletbeads and lozenges. Suitable lubricants include vegetable oils such ascoconut oil, magnesium Stearate, aluminum Stearate, talc, starch andCarbowax. Suitable non-cariogenic gums include kappa carrageenan,carboxymethyl cellulose, hydroxyethyl cellulose and the like.

U.S. Patent Application Publication No. 2008/00253976 discloses personalcare compositions, including compositions for oral, throat and skin carecomprising a blend of naturally occurring flavor or perfume ingredientsor essential oils containing such ingredients, wherein the blendprovides excellent antimicrobial activity and comprises at least twocomponents, a first acyclic component selected from citral neral,geranial, geraniol and nerol and a second cyclic-containing componentselected from eucalyptol, carvacrol and eugenol. The blend disclosed inthe '976 publication includes 3, 4, 5 or more of the above components.The '976 publication discloses compositions that are effective inkilling, suppressing the growth of, and/or altering metabolism ofmicroorganisms including those that cause undesirable oral cavityconditions including plaque, caries, calculus, gingivitis, periodontaldisease and malodor. Optionally the blend further comprises additionalantimicrobial and/or anti-inflammatory components, preferablynaturally-occurring as well.

U.S. Patent Application Publication No. 2006/0045851 discloses anessential oil composition comprising at least two essential oilsselected from Group A, which includes mint and spice essential oils andat least one essential oil selected from Group B, which includes citrusessential oils. The '851 publication discloses that the essential oilcomposition can effectively kill and remove oral microbials which arecorrelated to the formation of biofilm in the oral cavity, and that theessential oil composition can be combined with a variety of oralcarriers and actives.

WO 2012/012385 discloses compositions containing one or more derivativesof essential oil compounds for use in personal care compositions, suchas compositions for oral, throat and skin care. These derivativesinclude acetals of parent essential oil aldehydes and ketones; esters orethers of parent essential oil alcohols and phenolics; and esters ofparent essential oil acids. Examples of parent essential oil aldehydesand ketones include citral, cinnamic aldehyde, p-anisaldehyde, vanillin,ethyl vanillin, heliotropin, carvone, and menthone. Examples of parentessential oil alcohols and phenolics include thymol, eugenol,isoeugenol, dihydroeugenol, carvacrol, carveol, geraniol, nerol,vanillyl alcohol, heliotropyl alcohol, p-anisyl alcohol, cinnamylalcohol and β-ionol. Examples of parent essential oil acids includep-anisic acid, cinnamic acid, vanillic acid and geranic acid. Thecompositions comprising essential oil derivatives are useful as baseflavor or base perfume for incorporation into personal care products andto provide other benefits including antimicrobial efficacy. Thecompositions also can contain additional antimicrobially oranti-inflammatory-effective components including those also derived fromplant essential oils or synthetic versions thereof.

WO 1998/010110 discloses substantially water free tablets that, whenchewed in the mouth form a self-foaming paste containing stannousfluoride.

The tablet contains less than about 50% by weight of a compositionproducing carbon dioxide when mixed with the saliva in the mouth, andgreater than about 35% by weight of a substantially insoluble fillingand polishing composition, and a wetting and foam stabilizingcomposition that forms the paste. This document disclose that thefilling and polishing composition comprises greater than about 50% ofthe tablet and that the carbon dioxide producing composition comprisesless than about 25% by weight of the tablet. The tablet is water free toprevent degradation of the stannous fluoride before use. A tablet ischewed to form the paste. The paste is swished around in the mouth andbetween the teeth to perform a mechanical cleaning action and to bringthe stannous fluoride in contact with the tooth surfaces. The tabletthen is swallowed. Twice a day use is said to provide an anti-caries andanti-plaque effect greater than that heretofore achieved by any dentalhygiene product.

U.S. Pat. No. 8,858,920 discloses an oral care composition that includesxylitol and a water-soluble calcium salt for caries prevention. Methodsof treating and preventing dental caries are also disclosed. U.S. Pat.No. 6,207,138 discloses a method and composition for remineralizingteeth wherein the composition contains a mixture of a caseinglycomacropeptide and xylitol. U.S. Pat. No. 5,804,165 discloses anon-liquid oral dentifrice composition in the form of powder or tabletsthat is characterized by an efficacious ratio of carbon dioxide source,xylitol, acid source and silicon dioxide.

U.S. Pat. No. 6,054,119 discloses a dentifrice to protect the teeth,which preparation is anhydrous, with the possible exception of crystalwater, and by structure, for example a powder, solid tablet or otheranhydrous compositions. The preparation contains a remineralizingcomponent, a pH buffer component, xylitol, and fluoride. Due to theeffect of the water contained in the saliva or water added otherwise,the compounds in the preparation react with each other so as to bringabout both a remineralization reaction correcting cavity formation inthe teeth, and a pH buffering reaction prevention cavity formation inthe teeth.

U.S. Patent Application Publication No. 2007/0196477 discloses rapidlydisintegrating tablets that include a calcium phosphate material incombination with other common tablet components. Such a calciumphosphate material must exhibit a sufficiently low surface area in orderto boost the ability of the table to separate quickly when introducedinto a user's mouth cavity. Such a tablet is dimensionally stable priorto use (low friability) and, when immersed in water the tabletdisintegrates therein in less than about 60 seconds.

U.S. Pat. No. 6,238,648 discloses oral care compositions, includingtherapeutic rinses, toothpastes and gels comprising a combination of anon-cariogenic carbohydrate and polyalcohol. This patent furtherdiscloses a method for treating or preventing conditions in the mouththat favor formation of tooth caries. U.S. Patent ApplicationPublication No. 2005/0244343 discloses rapidly disintegrating oral caretablets that include a super disintegrant. The tablet comprises asilica; a super disintegrant; and a sugar alcohol. When immersed inwater the tablet has a friability of less than about 2% anddisintegrates in less than about 60 Seconds.

A rapidly disintegrating tablet also is disclosed in U.S. PatentApplication Publication No. 2005/0244492. The tablet comprises: titaniumdioxide; a super disintegrant; and a sugar alcohol. When immersed inwater the tablet has a friability of less than about 2% anddisintegrates in less than about 60 Seconds. U.S. Patent ApplicationPublication No. 2007/0254067 discloses a method of consumercustomization of oral care products in which the consumer can selectfrom customization agents to add to a base product.

Single use oral care products that include chewable products aredisclosed in U.S. Pat. No. 4,765,984. The single unit dose chewable oralproduct is stabilized against syneresis and includes an alginate gellingagent, cross-linked with a calcium ion, flavor and a liquid vehiclecontaining water, humectant and a vegetable oil additive to reducesyneresis. U.S. Pat. No. 4,308,252 discloses a dental prophylaxis tabletcontaining abrasives and anticaries agents. The tablet is hard enough towithstand normal storage and handling. The tablet also containsdispersing and wetting agents so that it may be readily constituted intoa dental prophylaxis paste by the addition of water and may containsweeteners and flavors. A typical tablet is approximately one gram inweight and has hardness of about 3.5 to 4.0 kilograms (Pfizer tester). Atypical tablet can be hydrated in approximately 60 seconds with theaddition of water to form a prophylaxis paste. A typical formulation is:feldspar 61%, Cabosil™ 1%, Instant ClearJel™ 5%, StaR 1500™ 25%, sodiumsaccharin 0.5%, sodium citrate 0.5%, stannous fluoride 5%, Stearowet-C™0.5% and flavors 1%.

Multi-part chewing gum tablets containing a variety of ingredientsincluding pharmaceutically active ingredients are disclosed in U.S. Pat.Nos. 8,603,440; 8,623,331; 8,722,022; 8,968,770; and 9,283,191. Thedisclosures of the all of the documents discussed above, and describedbelow, are incorporated by reference herein in their entireties.

A primary concern for the regular traveler or those working or engagingin sports and away from their residence is the maintenance of regulardental hygiene. This is particularly true for the traveler who may spendmany hours without facilities or dental hygiene supplies, such as atoothbrush, dentifrice, mouthwash and dental floss. Most persons noteafter a few hours, an unpleasant feeling of known bacteria and plaquebuildup which is usually accompanied by unpleasant breath, oftenundetected by the person directly but a condition or risk with which theperson is acutely aware. This latter problem has given rise to theincreasing popularity of spray type breath deodorizers and “breathmints.” The users of such sprays or lozenges fully recognize that theeffect is primarily cosmetic or masking and does not attack the realproblem of bacteria and plaque removal nor does it provide any cleaning,polishing or improvement in the condition of the surfaces of the teeth,gums, tongue, and surrounding mucosa of the mouth.

There are a number of limitations to good oral hygiene practices for theregular traveler or those working or engaging in sports and away fromtheir residence. One limitation is the unavailability of suitable waterand disposal facilities for the actual process associated with thecleaning procedures. Another limitation is the lack of privacy for theprocedures of brushing, rinsing, expectoration and cleanup. A thirdlimitation is the lack of reasonable cleanliness. An additionallimitation is the lack of convenience of being able to perform theprocedures. These principal limitations to good dental hygiene away fromhome are exemplified by the plight of the business traveler. A 14-hourday of sales calls rarely, if ever, includes a suitable facility withwater for brushing, rinsing, expectoration and clean-up. There are fewprivate areas for such procedures. Even if such an area could be found,it is most likely to be in the restroom of a less than frequentlycleaned road side filling station, usually inconvenient located, leadingto the further frustration of being unable to accomplish any dentalhygiene routine or procedure.

There exists a need for a safe, convenient, and effective dental andoral hygiene product that does not suffer from one or more of thelimitations discussed above. There also exists a need for such an oralhygiene product that is easy to carry and store for long periods oftime, and that is convenient to use even in the presence of others.

BRIEF SUMMARY

Embodiments described herein include an oral hygiene composition thatsatisfies one or more of these needs. The oral hygiene composition mayinclude natural powders pressed into tablet form that promote thehealthy effects of cleaning the teeth, tongue and gums, fresheningbreath, and removing plaque and buildup, while avoiding risks associatedwith traditional artificial and/or synthetic ingredients. An additionalfeature of the embodiments is that the composition avoids the taste of,and does not include sodium bicarbonate as a base. The embodimentsprovide a xylitol-based pressed tablet to reduce bacteria in the mouthand freshen breath, together with additional ingredients to whiten teethand protect enamel.

A feature of this disclosure is to provide natural powders pressed intotablet form that provide whitening, freshening and sanitizing similar tothat of traditional toothpaste, while avoiding risks associated withartificial and/or synthetic ingredients normally found in toothpaste.The tablets also are more convenient than brushing one's teeth. Inaccordance with one embodiment, the powder composition includes powderedxylitol and at least one tooth cleaning agent. In another embodiment,the composition further comprises kaolin as an abrasive, which may aidin removing plaque and other buildup from the surface of the teeth, andin another embodiment, the composition may further include fluoride.

Other embodiments including those in which the composition furtherincludes natural flavoring(s), such as peppermint oil or naturalwhitening ingredients such as activated charcoal or kaolin. In anotherembodiment, the composition might include aloe vera powder or coconutoil pressed into the tablets for protection of sensitive teeth and gums.Still other embodiments include methods of making the powder compositionthat includes mixing at least xylitol and a tooth cleaning agent,optionally granulating the xylitol and/or tooth cleaning agent(s),optionally drying the mixture, and pressing the mixture into tablet orcapsule form.

Both the foregoing general description and the following detaileddescription are exemplary and explanatory and are intended to providefurther explanation of the embodiments as claimed. Other objects,advantages, and features will be readily apparent to those skilled inthe art from the following detailed description of the embodiments.

DETAILED DESCRIPTION

The present disclosure concerns a pressed powder composition, preferablyin the form of a tablet or capsule, that can be used for cleaning andbrightening the teeth. In one embodiment, the powder compositionincludes a mixture of natural ingredients with a xylitol base. One ofthe features of the embodiments is to provide a natural toothpastealternative, which promotes similar desirable whitening, freshening,sanitizing results of traditional toothpaste, while avoiding risksassociated with artificial and/or synthetic ingredients and delivered ina hygienic, convenient and stable way.

Before the compositions, active agents, etc., and methods are described,it is understood that the embodiments are not limited to the particularmethodology, protocols, compositions, powders, etc., as these may vary.It also is to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto limit the scope of the present embodiments which will be limited onlyby the appended claims.

Terms and phrases used herein are defined as set forth below unlessotherwise specified. Throughout this description, the singular forms“a,” “an,” and “the” include plural reference unless the context clearlydictates otherwise. Thus, for example, a reference to “a powder”includes a plurality of powders, and a reference to “a natural flavor”is a reference to one or more natural flavors and equivalents thereofknown to those skilled in the art, and so forth.

The embodiments described herein preferably provide one or moreadvantages, in addition to those described previously, selected from:(a) whitening teeth; (b) reducing bacteria in the mouth; (c) includingantioxidants; (d) freshening breath; (e) avoiding artificial and/orsynthetic ingredients; (f) improving oral health; (g) having a pleasanttaste; (h) reducing or eliminating breath odor; (i) neutralizing pHlevels in the mouth; (j) neutralizing cariogenic bacterial acids; andremoving plaque from the surface of the teeth, bums, tongue andsurrounding mucosa in the mouth. These and other advantages of one ormore aspects will become apparent from consideration of the ensuingdescription and accompanying examples. Although the description abovecontains many specifics, these should not be construed as limiting thescope of the embodiments but as merely providing illustrations of someof several embodiments. Thus the scope of the embodiments should bedetermined by the claims that are appended and their legal equivalents,rather than by the examples given.

The citation of documents herein does not constitute an admission thatthose documents are prior art or have any relevance to the patentabilityof the embodiments disclosed herein. Any discussion of the content ofthe documents mentioned in the Introduction section is intended merelyto provide a general summary of assertions made by the authors of thedocuments, and does not constitute an admission as to the accuracy ofthe content of such documents. All documents described in thisspecification are hereby incorporated by reference in their entirety.

As used herein, the words “preferred” and “preferably” refer toembodiments of the invention that afford certain benefits, under certaincircumstances. However, other embodiments may also be preferred, underthe same or other circumstances. Furthermore, the recitation of one ormore preferred embodiments does not imply that other embodiments are notuseful, and is not intended to exclude other embodiments from the scopeof the invention.

As used herein, the word “include,” and its variants, is intended to benon-limiting, such that recitation of items in a list is not to theexclusion of other like items that may also be useful in the materials,compositions, devices, and methods of this invention. As referred toherein, all compositional percentages are by weight of the totalcomposition, unless otherwise specified.

As used herein, the term “about,” when applied to the value for aparameter of a composition or method of this invention, indicates thatthe calculation or the measurement of the value allows some slightimprecision without having a substantial effect on the chemical orphysical attributes of the composition or method. If, for some reason,the imprecision provided by “about” is not otherwise understood in theart with this ordinary meaning, then “about” as used herein indicates apossible variation of up to 5% in the value.

It is a feature of an embodiment to provide a compressible powdercomposition that includes powdered xylitol and at least one toothcleaning agent. In another embodiment, the composition further comprisesan abrasive such as kaolin, which may aid in removing plaque and otherbuildup from the surface of the teeth, and in another embodiment, thecomposition may further include fluoride. It also is a feature of theembodiments to provide the powder composition in the form of acompressed tablet or capsule. In addition, it is a feature of anembodiment to provide a method of making a compressed tablet or capsulethat includes powdered xylitol and at least a tooth cleaning agent.

Xylitol is a non-cariogenic carbohydrate and has a variety of usesincluding, but not limited to, a non-cariogenic sweetener, a humectant,and an anti-caries agent. While not intending to be bound by anyparticular theory, xylitol appears to cause a disturbance in themetabolism of fermentable carbohydrates by S. mutans and therebydecreases plaque formation and reduces plaque adhesion to the pellicle.Also, upon metabolizing xylitol, the toxic metabolitexylitol-5-phosphate forms within the S. mutans cells which may interferewith glycolysis energy production and may also involve anenergy-consuming futile cycle. The energy consuming cycle kills the S.mutans which results in reduced caries. Any xylitol may be used inaccordance with the embodiments, including xylitol readily available forsale on consumer web sites (e.g., Amazon, etc.), or commercial grade,directly compressible xylitol (DC xylitol) can be used. Xylitol may bepresent in the powder at about 10% to about 40% by weight, or from about15% to about 30% by weight, or from about 20% to about 25% by weight,based on the total weight of the composition.

The compositions also may contain additional anti-caries agents, andtaste-masking agents such as erythritol. Erythritol can be about 60% assweet as sucrose at practical use levels and is sweeter than mannitoland sorbitol, which are only 50% as sweet as sucrose under similarconditions. It has an advantage over propylene glycol and glycerol inhaving a clean and pleasant taste and it is very soluble in water (asaturated solution contains about 38% w/w). Unlike other polyols,erythritol is not significantly metabolized after oral ingestion inhumans, and so is of unique interest as a non-nutritive sweeteningagent. Commercially available erythritol is prepared as a whitecrystalline product by treating an aqueous alkali carbonate solution of2-buten-1,4-diol with chlorine and saponifying the resultingchlorohydrin. The natural product can be produced on a commercial scaleby propagating specially selected yeast strains in appropriate aqueousnutrient media. Any erythritol may be used in accordance with theembodiments, including erythritol readily available for sale on consumerweb sites (e.g., Amazon, etc.), or commercial grade, directlycompressible erythritol (DC erythritol) can be used. Erythritol may bepresent in the powder at about 10% to about 40% by weight, or from about15% to about 30% by weight, or from about 20% to about 25% by weight,based on the total weight of the composition.

The oral hygiene compositions described herein contain at least onetooth cleaning agent, and more preferably contain more than one toothcleaning agent. Tooth cleaning agents include those commonly known inthe art that are effective in cleaning teeth, such as abrasives,polishing agents, whitening agents, anti-bacterial agents, anti-fungalagents, anti-caries agents, etching agents, forming agents, surfactants,flavoring agents, coloring agents, and the like. The oral hygienecompositions also may contain additional components that are typicallyused in oral hygiene compositions and products.

An abrasive often provides a cleaning action for oral care productsincluding the removal of plaque, food debris, and the like. The abrasiveshould not damage the enamel of teeth, and it should have compatibilitywith other components of the composition. Suitable abrasives for use inthe embodiments can be selected from materials that do not causeexcessive erosion of tooth dentin leading to tooth sensitivity such ascalcium phosphate materials, including calcium pyrophosphate, tribasiccalcium phosphate, dibasic calcium phosphate dihydrate and anhydride,and calcium carbonate, as well as silica and aluminum hydroxide. Inaddition to those materials, natural fibrous materials such as celluloseand derivatives thereof, and natural materials such as shell powders ofeggs and shellfish may also be used as the abrasive.

The calcium phosphate material preferably is a calcined calciumphosphate material. Suitable pre-calcined calcium phosphates includedicalcium phosphate, also known as dibasic calcium phosphate, bothanhydrous (DCP) and dihydrate (DCPD) forms; tricalcium phosphate (TCP),also known as tribasic calcium phosphate; calcium pyrophosphate; calciumpolyphosphate and the like, and combinations of more than one calciumphosphate. Two potentially preferred calcium phosphates are calcined(defined herein as heating for up to 2 hours at 900° C.) EMCOMPRESS®dicalcium phosphate dehydrate which has a surface area of about 4 m²/g,and calcined TRI-CAFOS® P tricalcium phosphate which has a surface areaof about 6 m²/g. In one embodiment, the composition includes the calciumcomponent, preferably dicalcium phosphate, in an amount of from about10% to about 40% by weight, or from about 15% to about 30% by weight, orfrom about 20% to about 25% by weight, based on the total weight of thecomposition.

The composition may further comprise a fluoride-providing agent or afluoride-ion source that can be used as anti-caries agents. Thefluoride-providing agents typically should be sufficiently water solubleto release an anti-caries amount of fluoride ions in water or thesaliva. Suitable fluoride-providing agents are organic or inorganic.Inorganic fluoride ion-providing agents include metal, alkali metal,alkaline earth metal and ammonium salts of fluoride, such as for examplepotassium fluoride, sodium fluoride, ammonium bifluoride, calciumfluoride, a copper fluoride such as cuprous fluoride, barium fluoride,sodium fluorosilicate, ammonium fluorosilicate, sodium fluorozirconate,sodium monofluorophosphate, aluminum mono- and di-fluorophosphate,fluorinated sodium calcium pyrophosphate, stannous fluoride, lithiumfluoride, cesium fluoride, aluminum fluoride, cupric fluoride, indiumfluoride, stannous fluorozirconate, ferric fluoride, nickel fluoride,palladium fluoride, silver fluoride, zirconium fluoride, and mixturesthereof. Preferred inorganic fluoride ion-providing agents are sodiummonofluorophosphate and sodium fluoride.

Organic fluoride ion-providing agents include hexylamine hydrofluoride,laurylamine hydrofluoride, myristylamine hydrofluoride, decanolaminehydrofluoride, octadecenylamine hydrofluoride, myristoxyaminehydrofluoride, diethylaminoethyloctoylamide hydrofluoride,diethanolamineoethyloleylamide hydrofluoride,diethanolaminopropyl-N′-octadecenylamine dihydrofluoride,1-ethanol-2-hexadecylimidazoline dihydrofluoride, octoylethanolaminehydrofluoride, octyltrimethylammonium fluoride,dodecylethyldimethylammonium fluoride, tetraethylammonium fluoride,dilauryldimethylammonium fluoride, δ8-9octadecenylbenzyldimethylammonium fluoride, dioctyldiethylammoniumfluoride, cyclohexylcetyldimethylammonium fluoride,furfuryllauryidimethylammonium fluoride,phenoxyethylcetyldimethylammonium fluoride,N:N′-tetramethyl-N:N′-dilaurylethylenediammonium difluoride,N-cetylpyridinium fluoride, N:N-dilauryl-morpholinium fluoride,N-myristyl-N-ethylmorpholinium fluoride,N-(octylaminocarbonylethyl)-N-benzyldimethylammonium fluoride,N—(B-hydroxydodecyl)trimethylammonium fluoride,N-phenyl-N-hexadecyldiethylammonium fluoride,N-cyclohexyl-N-octadecyldimethylammonium fluoride,N-(2-carbomethoxyethyl)-N-benzyldimethylammonium fluoride,N-(2-carbocyclohexoxyethyl)-N-myristyldimethylammonium fluoride,N-(2-carbobenzyloxyethyl)-N-dodecyldimethylammonium fluoride,N-[2-(N:N′-dimethylaminocarbonyl)-ethyl]-N-dodecyldiethylammoniumfluoride, N-carb oxymethyl-N-cicosyldimethylammonium fluoride, olaflur(N′-octadecyltrimethylendiamine-N,N,N′-tris(2-ethanol)-dihydrofluoride),betaine hydrofluoride, sarcosine stannous fluoride, alanine stannousfluoride, glycine potassium fluoride, sarcosine potassium fluoride,glycine hydrofluoride, lysine hydrofluoride, alanine hydrofluoride,betaine zirconium fluoride, and mixtures thereof.

The fluoride-providing agent, if present, may be present in an amountsufficient to release between about 200 ppm to 3000 ppm fluoride ion,preferably from about 800 to about 1500 ppm fluoride ion. Thefluoride-providing agent may be present in the composition from about0.001% to about 3% by weight.

The powder compositions also may include a forming agent and/or asurfactant to not only clean teeth, but also to assist in the formationof bubbles. Generally, the forming agent may include an anionicsurfactant, a cationic surfactant, a non-ionic surfactant, an amphotericsurfactant, or a zwitterionic surfactant. The forming agent may be asingle material or a combination of two or more materials. Suitableforming agents include, for example, a safe and effective amount ofsodium lauryl sulfate, sodium coconut monoglyceride sulfonate,sarcosinate, e.g. sodium lauroyl sarcosinate, taurate, sodium laurylsulfoacetate, sodium lauroyl isethionate, sodium laureth carboxylate andsodium dodecyl benzene sulfonate. In addition, cocamidopropyl betaine,Poloxamer, sorbitan monooleate, PEG-40 sorbitan isostearate or a mixturethereof may also be used as the surfactant.

It is preferred that the powder composition not contain sodium laurylsulfate, although if used, the amount of sodium lauryl sulfate should beless than 5% by weight, or less than about 4%, or less than about 2%, orless than about 1% by weight. It is advantageous instead to usesarcosinate or sodium lauryl sulfoacetate. In one embodiment, thecomposition includes the forming agent, preferably sodium laurylsulfoacetate, in an amount of from about 5% to about 30% by weight, orfrom about 10% to about 20% by weight, or from about 13% to about 16% byweight, based on the total weight of the composition.

In addition to the calcium phosphate material, the powder compositionsmay contain other calcium-containing compounds, including naturalcalcium-containing compounds that can be used as an abrasive. Anembodiment therefor includes a powder composition that includes kaolin,or calcined kaolin, or purified calcined kaolin, such as the kaolindescribed in, for example, U.S. Pat. No. 4,122,163, the disclosure ofwhich is incorporated by reference herein in its entirety. In oneembodiment, the composition includes the natural calcium-containingcompound, preferably kaolin, in an amount of from about 1% to about 30%by weight, or from about 5% to about 20% by weight, or from about 8% toabout 12% by weight, based on the total weight of the composition.

The powder compositions also may contain additional abrasive ingredientssuch as sodium bicarbonate or stabilized sodium percarbonate. The sodiumbicarbonate ingredient of the embodiments functions as a soft abrasive,and additionally it imparts a clean and fresh feel in the oral cavitywhen a toothpaste formulation is utilized. The sodium bicarbonatepreferably has an average particle size between about 5-200 microns.Because of the bitter taste of sodium bicarbonate, if it is used in thepowder compositions, it is used in amounts less than 20%, or less thanabout 10%, or less than about 5% by weight, based on the total weight ofthe composition. In some embodiments, sodium bicarbonate is used inamounts within the range of from about 0.1% to about 10% by weight, orfrom about 1% to about 5% by weight, or from about 2% to about 4% byweight, based on the total weight of the composition.

The powder compositions of the embodiments also may contain flavorants,colorants, dyes, natural preservatives, and the like. In an embodiment,the contain flavorants, colorants, dyes, etc., may be selected fromnatural materials, and preferably are extracts of plant materials.Suitable ingredients may contain, for example, a natural mint flavoringproduct obtained from a plant of the Menthe genus and the Lamiaceaefamily, or an artificial counterpart of the natural product. L-Mentholhas a unique refreshing taste, a minty odor and a pronounced coolingeffect on the skin and mucosa. L-Menthol is the main constituent of thepeppermint oils from Mentha arvensis (content: 70 to 80%) and Menthapiperita (content: 50 to 60%). L-Menthol can be obtained from the crudepeppermint oil by crystallisation. In some embodiments, the powdercomposition contains menthe in the form of menthol crystals in an amountof from about 0.01% to about 5% by weight, or from about 0.1% to about3% by weight, or from about 1% to about 3% by weight, based on the totalweight of the composition.

Suitable natural preservatives may include, for example, any ingredientsuch as a solid, liquid, vapor, extract, compound, derivative, bioactivecomponent(s), etc. from any part of; a seed, root, rhizome, leaf, bark,plant, fruit and/or vegetable consisting of at least one of thefollowing: Agave (Genes Agave), Algae (Spirulina), Allium Family(Onions, Garlic, Chives, Leeks, Shallots and Scallions), Amla(Phyllanthus emblica), Apple (Malus domestica), Apricot (Prunusarmeniaca), Araca-Boi (Eugenia stipitata), Aronia (Aronia melanocarpa),Artichokes (Cynara cardunculus), Arugula (Eruca sativa), Ashwagandha(Withania somnifera), Avocado (Persea gratissima), Banana (Musa spp.),Barley Grass (Hordeum vulgare), Bell Peppers (Capsicum frutescens), Beet(Beta vulgaris), Bergamot (Citrus bergamia), Bilberry (Vacciniummyrtillus), Bitter Yam (Dioscorea bulbifera), Blackberry (Rubusvillosus), Black Johannisberry (Genes ribes), Boysenberry (Rubus ursinusx idaeus), Broccoli (Brassica oleracea italica), Broccoli Rabe (Brassicarapa), Brussels Sprouts (Brassica oleracea var. gemminfera), Cabbage(Brassica oleracea var. capitata), Cauliflower (Brassica oleracea var.botrytis), Caja (Spondias dulcis), Camu-Camu (Myrciaria dubia),Cantaloupe (Cucumis melo), Carrot (Daucos carota), Cashew (Anacardiumoccidentale), Celery (Apium graveolens), Chamomile (Matricaria recutitaand Chamaemelum nobile), Cherry (Prunus cerasu), Chili (Rosaroxburghii), Chinese Goldthread (Coptis chinensis franchinflorescence),Choriyanam (Tragia involucrate), Cocoa (Theobroma cacao), Coconut Milk(Cocus nucifera), Coconut Water, Coffee (Coffea arabica), Coffeeberry,Cranberry (Vaccinium macrocarpon), Crenshaw (Cucumis melo), Cucumber(Cucumis sativa), Cupuacu (Theobroma grandiflorum), Dates (Phoenixdactylifera), Dragon Fruit (Hylocereus undatus), Elderberry (Sambucusnigra), Fig (Ficus glomerata), Gac (Momordica cochinchinensis), Ginger(Zingiber officinalis), Ginseng (Panax ginseng), Golden Root (Rhodiolarosea), Graviola (Annona muricata), Grapefruit (Citrus paradisi),Greenbean (Phaseolus vulgaris), Guarana (Paullinia cupana), Guava(Psidium guajava), Guavasteen (Feijoa sellowiana), Honeydew (Cucumismelo), Indian Kudzu (Pueraria tuberosa), Jiaogulan (Gynostemmapentaphyllum), Juniper (Juniperus communis), Kale (Brassica oleracea),Kiwi (Actinidia chinensis), Lemon (Citrus limonum), Licorice(Glycyrrhiza glabra), Lingonberry (Vaccinium vitis-idaea), Loganberry(Rubus loganobaccus), Lulo (Solanum quitoense), Maitake Mushroom(Grifola frondosa), Mango (Mangifera indica), Maralu (Rhaponticumcarthamoides), Marking Nut Tree (Salacia reticulata), Miracleberry(Synsepalum dulcificum), Mulberry (Morus alba, Morus rubra, Morusnigra), Mulberry (Morus alba, Morus rubra, Morus nigra) With1-deoxynojirimycin (DNJ), Muskmelon (Cucumis melo), Nashi (Pyruspyrifolia), Nectarine (Prunus persica), Neem (Azadirachta indica), Noni(Morinda citrifolia), Olive (Elaeagnus angustifolia), Orange (Citrusaurantium), Papaya (Carica papaya), Parsley (Petroselinum crispum),Passion Flower (Passiflora incarnate), Passion Fruit (Passifloraedulis), Peach (Prunus persica), Pear (Pyrus communis), Pepper (Pipernigrum), Persimmon (Diospyros virginia), Pineapple (Ananas comosus),Pinyin (Schisandra chinensis), Plum (Prunus umbellate), Prune (Prunusdomestica), Pumpkin (Cucurbita pepo), Quebracho (Aspidospermaquebracho-blanco & Schinopsis lorenzii), (Quince (Cydonia oblonga),Raisins (Vitis vinifera), Raspberry (Rubus idaeus), Red Wine, Rhubarb(Rheum rhabarbarum), Spinach (Spinacia oleracea), Sprout (Brassicaoleracea gemmifera), Soy (Glycine max), Star Fruit (Averrhoa carambola),Strawberry (Fragaria virginiana), Sun Flower (Helianthus annuus), SweetPotato (Ipomoea batatas), Swiss Chard (Beta vulgaris), Tangerine (Citrusreticulate), Tarragon (Artemisia dracunculus), Tomato (Solanumlycopercicum), Turnips (Brassica rapa), Velvet Bean (Mucuna pruriens),Watermelon (Citrullus vulgaris), Watercress (Nasturtium officinale),Winter Cherry (Withania somnifera), Yohimbe (Pausinystalia johimbe),Yumberry (Myrica rubra) and Yuzu (Citrus ichangensis x C. reticulata).

Particularly preferred natural ingredients include Mentha piperita(peppermint oil), Citrus sinensis (sweet orange oil), and combinationsthereof. When used in the powder compositions, the natural preservativesand flavorants can be used in relatively minor amounts ranging fromabout 0.0001% to about 0.1%, or any value therebetween.

The powder compositions may be formulated into a tablet by mixing atleast xylitol and a tooth cleaning agent, optionally granulating thexylitol and/or tooth cleaning agent(s), optionally drying the mixture,and pressing the mixture into tablet or capsule form. The tablet may beprepared by mixing powdered materials and compacting the mixed powder ina press to form a tablet. Alternatively, the tablet may be prepared bymixing a combination of powder materials and liquid or gel materials,granulating the mixture or spray drying the liquid onto the powdermaterial. Other methods of mixing the components of the powdercomposition also may be used, as will be appreciated by those skilled inthe art. For example, granulators, blenders, fluid bed granulators,mixing devices for liquids and powders, grinders, and the like can beused.

The components should be sufficiently ground to an appropriate mesh sizeto be suitable for tableting. The components may have an averageparticle size within the range of from about 1 to about 1,000 μm, orfrom about 100 to about 800 μm, or from about 150 to about 600 μm. Thevarious components may have the same, similar, or different particlesizes and particle size distribution. Those skilled in the art will becapable of determining the appropriate mesh size of the variouscomponents, as well as the ultimate blend, to achieve the appropriatestrength in the tablet. See, e.g., Sun, et al., “Particle SizeSpecifications for Solid Oral Dosage Forms: A Regulatory Perspective,”Am. Pharm. Rev., Vol. 13(4) (2010).

Typically, the compositions described herein can be mixed in dry form toform a uniformly dispersed powdered mixture and then tableted on atableting machine, of a type known in the art, to a suitable hardness.The tablets may be of any convenient type, size, shape, or the like.Tablets of ½-2 grams each usually are sufficient, and one or moretablets may be consumed at a time, as required. Hardnesses in the rangeof about 3 to 8 kilograms crushing strength are satisfactory. It will beappreciated that the hardness (strength) of the tablets should beeffective to maintain the structural integrity of the tablets throughoutproduction, packaging, handling, transportation, storage and use tomaintain a consistent dosage and tablet size. In addition, the tabletshould be hydratable and must retain the ability to hydrate throughoutthe above conditions.

The tablet may optionally be coated with a coating material such aswaxes, shellac, carboxymethyl cellulose, polyethylene/maleic anhydridecopolymer or kappa carrageenan to further increase the time it takes thetablet to dissolve in the mouth. An uncoated tablet is slow-dissolving,providing a sustained release rate of active ingredients of about 3 to 5minutes, depending upon the size of the tablet.

Illustrative embodiments of the invention are described below. Theshowings are for purposes of illustrating preferred embodiments and notfor purposes of limiting the same. The following explanation providesspecific details for a thorough understanding of an enabling descriptionfor these embodiments. One skilled in the art will understand that theinvention may be practiced without such details. In other instances,well-known structures and functions have not been shown or described indetail to avoid unnecessarily obscuring the description of theembodiments.

Examples

In order to more adequately describe what the inventor regards as herinvention, the following example is provided. It should be understoodthat the formulations set forth in the Example are not to be construedas limiting of the scope of the invention, except so far as they yieldnatural tooth powders having desired properties and characteristics tonot only clean teeth but have the ability to be pressed into tablets.

The following table provides an exemplary tablet formulation of the samewith the percentages given by weight of the toothpaste.

TABLE 1 Ingredient Weight percent Dicalcium phosphate 23.45 Xylitol23.45 Erythritol 23.45 Sodium Lauryl Sulfoacetate 15.64 Kaolin 9.12Sodium bicarbonate 3.26 Menthe (menthol crystals) 1.63 Mentha piperita(Peppermint Oil) q.s. Citrus sinensis (Sweet Orange Oil) q.s.

The materials were processed and tableted using bench-scale devices.Those skilled in the art will appreciate that industrial scale equipmentcould be used, as well as commercial grade readily compressibleingredients. The xylitol and erythritol were ground in a hand held saltgrind attached to a hand drill. The particle size of the xylitol,erythritol, and menthol were about 600 μm, or at or about 30 Mesh.Commercially available xylitol and erythritol were used.

Commercially available Menthe (mentholcrystals—1R,2S,5R-2-isopropyl-5-methylcyclohexanol) then was groundusing a mortar and pestle, and sifted through an approximately 30 Meshsieve to provide menthe granules having a particle size of about 600 μm.The menthe, xylitol, and erythritol then were combined with theremaining dry ingredients, dicalcium phosphate, kaolin, sodium laurylsulfoacetate, and sodium bicarbonate in a plastic container, thecontainer was enclosed with a lid and then shook by hand for about 3minutes until properly mixed. The essential oils (peppermint and sweetorange) then were added to the dry mixture in the plastic container, andthe material was mixed by hand to crumble the materials together, andthen shaken for about 2 minutes until fully blended.

The mixed components then were tableted using a table-top tablet press,TDP 5 Desktop Tablet Press from LFA Machines Oxford Ltd. The toothpowder tablets then were made using a 0.4 gram, 20 mm diameter sizetablet setting, with a circular, beveled edge die. The components weresubjected to a maximum pressing pressure of about 50 Kn.

Particularly preferred embodiments have been described herein. Thoseskilled in the art will appreciate that various modifications may bemade to the formulation, as well as its method of manufacture, withoutdeparting from the spirit and scope of the embodiments.

What is claimed is:
 1. A method of making a compressible powdercomposition comprising: (a) mixing from about 10% to about 40% by weightxylitol and from about 10% to about 40% by weight erythritol to form auniform mixture; (b) optionally grinding the uniform mixture so that thexylitol and erythritol each has a particle size within the range of fromabout 100 to about 800 μm; (c) adding to the uniform mixture from about0.01% to about 5% by weight of a first flavorant having a particle sizewithin the range of from about 100 to about 800 μm to form a flavoreduniform mixture; (d) adding to the flavored uniform mixture from about10% to about 40% by weight of at least one tooth cleaning agent, lessthan 5% by weight sodium bicarbonate, from about 1% to about 30% byweight of a natural calcium-containing compound, and at least oneadditive selected from the group consisting of a second flavorant, acolorant, a dye, a natural preservative, and mixtures thereof, to form acompressible mixture; (e) blending the compressible mixture for a periodof time sufficient to form a substantially uniformly blendedcompressible powder composition.
 2. The method according to claim 1,further comprising compressing the compressible powder composition intoa tablet.
 3. The method according to claim 1, wherein the at least onetooth cleaning agent is selected from the group consisting of abrasives,polishing agents, whitening agents, anti-bacterial agents, anti-fungalagents, anti-caries agents, etching agents, forming agents, surfactants,and mixtures thereof.
 4. The method according to claim 3, wherein the atleast one tooth cleaning agent is at least one abrasive.
 5. The methodaccording to claim 4, wherein the at least one abrasive is dicalciumphosphate.
 6. The method according to claim 1, wherein the naturalcalcium-containing compound is kaolin.
 7. The method according to claim1, further comprising adding in (d) from about 2% to about 4% by weightsodium bicarbonate.